Design, Build, and Test Precision Medical Devices

Medical Devices

We specialize in the innovative development of electro-mechanical FDA classified devices.

Our regulatory and quality foundations have been developed through our rigorous R&D processes. They’ve been scrutinized through acquisitions and audits, and have been praised through both. Our experience and expertise in developing medical devices through regulated processes is crucial to maintaining speed and efficiency resulting in a more robust process and better products.

We don’t just say it; we do it. Our medical device start-up mentality helps us think and act differently, which gives advantages to clients both large and small.


Understand the Standards

Unsure of what standards your device needs to meet? Designing and testing to the appropriate standards can be confusing, time-consuming, and expensive. We have the depth of understanding to know what is required and with a quick call, we can give you an overview of what you’ll need.

SCHEDULE A STANDARDS REVIEW

  • Certified to ISO 13485:2016
  • Compliant to 21 CFR Part 820
  • DHFs
  • Risk Management
  • FMEAs (Usability, Design, Process)
  • Verification Testing
  • Validation Testing
  • Reliability Testing

  • Electrical Safety Testing (IEC 60601-1)
  • EMC Testing (IEC 60601-1-2)
  • Emissions Pre-Screening
  • IEC 62304 Medical Device Software
  • Formative & Summative Usability Testing
  • Environmental Testing
  • 510(k) Submissions

IEC 60601 EMC & Electrical Safety Testing

One of the most frequent inquiries we get is about understanding electrical safety and emissions testing. We’ve gone through the standards extensively and we can help you understand what’s required and what’s not.

IEC 62304 Medical Device Software Development

Our in-house medical device software is written per IEC 62304. We can help get yours under compliance, either by working with us or just some simple guidance and review.

FMEAs

Independent review of design, process, and usability failure modes is an important step in medical device development. Our talented team can tackle your FMEAs, giving you confidence that a broad range of thinking has reviewed and influenced your design.

THE PROCESS

Design Controls For Success

Tie it all together

Here's what's next

WHAT WE'VE DONE

Our Work

An Experienced Viewpoint

Medical Device Design Reviews

We are experienced medical device designers, engineers, manufacturers, and regulatory experts. With all of the testing and regulation surrounding medical device development, it pays to have outside experts offer other viewpoints, giving you peace of mind to keep moving forward.

SCHEDULE A DESIGN REVIEW